Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Quantifying Single-Use Waste Produced During mAb Manufacture

Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.

GUEST COLUMNISTS

Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
Navigating GMP Biosafety Challenges In ATMP Manufacturing
BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.
Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.
February 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.
All The Ways Global Biopharma Still Grapples With Annex 1
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

PHARMA OUTSOURCING WHITE PAPERS

Analytical Approach For Bispecific Antibody Quality Study
Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.

Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing
Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Forward-looking companies are onshoring critical programs to mitigate risks to supply chains, IP, and regulatory timelines.
Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.
Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
FIH: Reach Milestones Sooner With A Technology-Driven Approach
Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.